
Record of Telephone Conversation, August 2, 2011, Anascorp

 
 
 

Submission Type: BLA    Submission ID: 125335/0    Office: OBRR

Product:

Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection

Applicant:

Rare Disease Therapeutics, Inc. (RDT)

Telecon Date/Time: 02-Aug-2011 12:10 PM        Initiated by FDA? Yes

Telephone Number: (619) 328-5370

Communication Categorie(s):

1. Other - Post Marketing Commitments

 

Author: DONALD ERTEL

Telecon Summary:

PMC follow-up

FDA Participants: Donald Ertel

Non-FDA Participants: RDT: Jennifer Spinella

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:



RDT submitted the draft of the PMCs and written commitments discussed in the teleconference on 08/02/11@ 11:30am. 

Discussion: We found the content, and expected completion of Dec 31, 2011 to be acceptable. 

I stated that we expect to see --------------------(b)(4)-----------------------------.

RDT stated that they will submit an amendment to the submission for the PMCs and written commitments today, 08/02/11. 

Call ended 12:20 PM